QA Design Specialist

HemoCue, sedan april 2013 en del av Radiometer Group, är ett världsledande företag inom patientnära testning. HemoCue AB, beläget i Ängelholm, introducerade 1982 det första patientnära hemoglobintestet. Företaget säljer även patientnära tester för glukos, urinalbumin, HbA1c, totala antalet vita blodkroppar (B-LPK) och 5-partsdiff. Besök vår hemsida för mer information hemocue.com

Our Quality Assurance department needs reinforcement; therefore we are looking for a

QA Design Specialist

The Quality Assurance group is part of the RA/QA department and responsible for quality assurance and quality development activities within the core processes Supply Chain Management and Product Lifecycle Management. This includes QA expertise during product development, production and also further development of the already released products and manufacturing processes, handling of non-conformities as well as the qualification and maintenance of suppliers.

The Job

To become successful, you must support the organization with QA expertise by cooperating cross-functionally with other departments. Your main responsibilities and tasks will include:

Act as QA Core team member in Development Project performing activities according to HemoCue’s Product Life Cycle Management process Supporting organization with Design Control expertise Ensure that procedures and activities related to Design Control are in compliance with requirements in ISO 13485 and QSR as well as with industry best practice Ensure that Design Changes (to product and manufacturing process) are planned and implemented according to the Engineering Change Control Procedure and relevant considerations are taken regarding quality and regulatory requirements
Qualifications You have a University degree in science or technology (Master or Bachelor)

Experience from the following areas is required:

Minimum three years of experience from Medical Device Industry Minimum three years of experience in Design Control in a QA function Knowledge and trained in Design Control (QSR 820.30) Knowledge in ISO 13485 and QSR Good knowledge of Swedish and English in speech and writing are essential
Personality As a person you are conscientious, proactive and organized. You are a team player, efficient, structured and solution-oriented and who likes a fast pace. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.

Interviews will be held as soon as relevant candidates have been identified

Interviews will be held as soon as relevant candidates have been identified. Send your application via www.hemocue.com/jobbsidan . We are not able to receive your application by other means than through “jobbsidan“. Please bring diplomas for face-to-face interviews. Any application by mail or e-mail will be returned.

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. Also we offer you opportunities for training and career development.

We are looking forward to receiving your application.

For further information, please contact Quality Assurance Manager, Anna Stegmark at tel. +46 734 14 05 50.

Union information is available from Patrik Heimby, Unionen, +46 431-48 14 10 or Lars Bergman, Akademikerföreningen, +46 431-48 15 60.